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ALX Cosmetic Hand, Women, Left, Large, 8

by Koalaa Ltd United Kingdom EUDAMED

Ref KCH188Model ALX

EMDN Y061809

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506108178ALXBE4X Basic UDI-DIDate29 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Alx Below Elbow Prosthesis
Model / Reference
ALX, KCH188
Primary DI / UDI-DI
05061081782761
Basic UDI-DI
506108178ALXBE4X
Direct Marketing DI
05061081782761
EMDN Code
Y061809 Transradial prostheses (for amputation under elbow)
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
UK-MF-000045260
Authorised representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

Other devices from Koalaa

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Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 36f0d55c-5015-4b57-bcb4-36ea8ad13a22 61 fields · synced 22 Oct 2026